Cleaning in place (CIP)

Overpressure spray principle
Automated system guaranteeing coverage close to 100% of the surfaces to be cleaned
Nozzle arrangement of fixed and rotary columns positioned in strategic locations
Used cleaning agents which may be water, solvent, antiseptic
One or more recirculation cycles that minimize consumer product cleaning

Sterilization in place (SIP)

Pure steam introducing or other pressurized products allowing the elimination of bacteria remaining in the facility
Our devices are designed to withstand the stresses of vacuum and pressure required by the sterilization cycle (bursting disc protection)
Validation provided by a filtration system with integrity test in place
Process mastered by monitoring and recording of data with SCADA

Lock device

The sterilizable chambers are equipped with an efficient door closing and secured system to be in compliance with pharmaceutical standards for pressure vessels.

Sealing device dual seal:
- an inflatable seal for the cleaning and sterilization cycles
- an O-ring vacuum stage
Automatic or manual secure locking doors with PLC

Unifluid™ refrigeration system

The UNIFLUID™ concept is to use the same heat transfer fluid to heat and cool both the shelves and condenser of the freeze dryer (trap), independently.

Precise control of the temperature of the shelves independently of cooling of the condenser
Improved freezing rate
System permits the use of refrigeration units combined compressor system with liquid nitrogen (LN2) acting as booster cryogenic expansion

CAL 21™ supervision

Specialized and customized batch management system developed by SERAIL
CAL 21™ combines:
- a supervisor PC (SCADA with Wonderware ® interface for monitoring and data acquisition)
- a programmable logic controller (PLC to the method of control)
Last generation for the control/command, the system meets the requirements of 21 CFR 11 and the new Annex 11 of the EU-GMP and cGMP

Technology